Standard Bougie

K191885 · Standard Bariatrics · KNT · Apr 8, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K191885
• Device Name: Standard Bougie
• Applicant: Standard Bariatrics
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Apr 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectorny procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

Device Story

Standard Bougie is a single-patient-use, non-sterile gastrointestinal tube; 80 cm length, 18 French diameter. Device features distal balloon, multiple holes, and proximal luer connector. Used in surgery centers/hospitals by surgeons during vertical sleeve gastrectomy. Surgeon inserts tube orally into stomach; connects proximal end to hospital suction for decompression/drainage/irrigation. Balloon inflated/deflated via syringe at luer connector to serve as sizing guide. Device aids in stomach sizing and fluid management; facilitates surgical workflow; benefits patient by assisting in precise gastric sleeve formation.

Clinical Evidence

Bench testing only. Performance data includes drainage flow rate verification, balloon strength and size verification, tensile strength verification, reliability testing, and device usability assessment.

Technological Characteristics

Thermoplastic elastomer construction; double lumen design; 18 Fr diameter; 95 cm length. Features distal balloon for sizing, proximal luer connector for inflation/suction, and depth markings. Supplied non-sterile for single-patient use. Materials compliant with ISO 10993.

Indications for Use

Indicated for patients undergoing vertical sleeve gastrectomy procedures requiring stomach decompression, drainage, irrigation, and sizing.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Boehringer Laboratories Gastric Sizing Tube (ViSiGi) (K130483)

Reference Devices

• Cook Incorporated Gastric Sizing Balloon Catheter (K173355)

Submission Summary (Full Text)

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April 8, 2020

Standard Bariatrics Alison Sathe Regulatory 4362 Glendale Milford Rd. Cincinnati, OH 45242

Re: K191885 Device Name: Standard Bougie Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 9, 2020 Received: March 11, 2020

Dear Alison Sathe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls' provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Daniel G. Walter, Jr. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191885

Device Name Standard Bougie

Indications for Use (Describe)

The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectorny procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

Type of Use (*Select **one** or **both**, as applicable*)> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(K) Summary

#### I. SUBMITTER

Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA

Phone: [phone] Email: [e-mail]

Contact Person: Alison Sathe Date Prepared: July 12, 2019

DEVICE II.

Name of Device: Standard Bougie Common or Usual Name: Gastrointestinal tube and accessories Classification Name: Tubes, Gastrointestinal (And Accessories) (21 CFR 876.5980) Regulatory Class: II Product Code: KNT

#### III. PREDICATE DEVICE

Predicate Device: Boehringer Laboratories Gastric Sizing Tube (Tradename: ViSiGi), K130483 Reference Device: Cook Incorporated Gastric Sizing Balloon Catheter, K173355

#### IV. DEVICE DESCRIPTION

The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide.

The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

#### V. INDICATIONS FOR USE

The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Standard Bougie technological characteristics are provided in Table 1.

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### Table 1: Technological Characteristics

| Product | Standard Bougie<br>(subject device) | ViSiGi<br>(Boehringer Laboratories<br>Gastric Sizing Tube-<br>K130483) | Equivalence |
|------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Typical Use | Gastric and bariatric surgical<br>procedures | Gastric and bariatric surgical<br>procedures | Same |
| Use Environment | Surgery centers, hospitals | Surgery centers, hospitals | Same |
| Patient Population | Patients undergoing bariatric<br>and/or gastric procedures | Patients undergoing bariatric<br>and/or gastric procedures | Same |
| Single Patient Use | Yes | Yes | Same |
| Sterility | Supplied non-sterile, single<br>patient use only, disposable | Supplied non-sterile, single<br>patient use only, disposable | Same |
| Functionality | Suction, drainage, irrigation<br>and sizing | Suction, drainage, irrigation<br>and sizing | Same |
| Method of Application | Insertion into the mouth and<br>manually advance the distal<br>end into the desired location<br>within the stomach | Insertion into the mouth and<br>manually advance the distal<br>end into the desired location<br>within the stomach | Same |
| Tubing Design | Double lumen with rounded,<br>closed distal end | Single lumen with rounded,<br>atraumatic distal end | Equivalent. The Standard<br>Bougie double lumen is<br>provided to allow for<br>inflation of the balloon |
| Diameter | 18 Fr | 32 Fr, 36 Fr, or 40 Fr | Equivalent. The smaller<br>size Standard Bougie is<br>provided for surgeon<br>preference as some prefer<br>a smaller size lumen. 18Fr<br>is a standard size for<br>bougie devices and many<br>are available in 18Fr.¹ |
| Length | 95 cm | 76 cm | Equivalent. The Standard<br>Bougie is slightly longer<br>than the ViSiGi. Both<br>devices are long enough to<br>perform their intended use.<br>The Standard Bougie is<br>slightly longer in order to<br>ensure adequate length for<br>the inflation lumen. |
| Materials | Thermoplastic elastomer | Styrene-Ethylene-Butylene-<br>Styrene (SEBS Copolymer) | Equivalent. Both devices<br>utilize materials compliant<br>with ISO 10993 for their<br>intended use. Both have<br>similar mechanical<br>properties to allow for<br>their intended use. |
| Connection for suction | Yes | Yes | Same |
| Method of Suction | Connection with hospital | Connection with hospital | Same |
| | apply suction within the<br>stomach | apply suction within the<br>stomach | |
| Markings | Yes (numbers every 10 cm<br>and gradations every 5 cm) | No | Equivalent. Markings are<br>provided on the Standard<br>Bougie to aid in device<br>placement but are not<br>necessary for the device<br>use. |
| Packaging | Tyvek pouch for single device<br>with 6 pouched devices within<br>a cardboard box | Plastic pouch for a single<br>device with 5 pouched devices<br>within a cardboard box | Equivalent. Both devices<br>are packaged nonsterile in<br>a pouch with a cardboard<br>outer package |

¹ The Cook Gastric Sizing Balloon cleared pursuant to K173355 is 18Fr and is provided as an example of a currently marketed 18Fr diameter bougie.

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#### VII. PERFORMANCE DATA

Standard Bougie performance testing has been submitted in this 510(k) as follows:

- Drainage Flow Rate Verification -
- -Balloon Strength Verification
- -Balloon Size Verification
- -Tensile Strength Verification
- -Reliability Testing
- Device Usability -

#### VIII. CONCLUSIONS

The Standard Bougie has the same intended use, and principles of operation as its predicate device. The minor differences in technological characteristics do not raise new questions of safety or effectiveness and testing demonstrates substantial equivalence. The Standard Bougie is substantially equivalent to the predicate device.